NCT03720483

Inhaled NAC in Treatment of IPF

Pilot Study to Evaluate Inhaled N-Acetylcysteine in Pulmonary Fibrosis

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study plans to learn more about the safety and tolerability of inhaled N-Acetylcysteine (NAC) in patients with pulmonary fibrosis. The study will also create a bank of data, blood, and sputum from IPF patients for future research.

Detailed description

This study plans to learn more about the safety and tolerability of inhaled N-Acetylcysteine (NAC) in patients with pulmonary fibrosis. The study will also create a bank of data, blood, and sputum from IPF patients for future research. NAC is a medication used to loosen thick mucus. NAC was initially licensed for use in 1968. It is on the World Health Organization's List of Essential Medicines, the most effective and safe medicines needed in a health system, and it is available as a generic medication and is not very expensive. Inhaled NAC has been used as a mucus-dissolving therapy in respiratory conditions with excessive and/or thick mucus production.

Conditions

• Idiopathic Pulmonary Fibrosis (IPF)

Interventions

Type	Name	Description
DRUG	N-acetyl cysteine then Placebo	Subject will receive N-acetyl cysteine first followed by Placebo
DRUG	Placebo then N-acetyl cysteine	Subject will receive Placebo first followed by N-acetyl cysteine

Timeline

• Start date: 2022-01-01
• Primary completion: 2023-12-01
• Completion: 2023-12-01
• First posted: 2018-10-25
• Last updated: 2021-06-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study